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Regulatory Affairs Specialist
8 hours ago
We're seeking an experienced professional to join our team as a QPPV/Safety Manager. This role involves managing Drug Safety in line with company policies, SOPs, and regulatory requirements.
Responsibilities:
- Manage QPPV responsibilities for certain clients.
- Oversee Post marketing Safety-only projects.
- Prepare safety sections in various regulatory documents.
- Conduct literature reviews.
- Collect, assess, and enter spontaneous adverse event reports into the safety database in line with client SOPs and regulatory requirements.
- Review and approve processed cases and AE/SAE reconciliations.
- Coding of adverse events, medical history, and concomitant medication according to MedDRA and WHO-Drug Dictionary.
- QC and approval of coded data.
- Electronic submission of reports to EudraVigilance.
- Contribute to post-approval surveillance plans and SOPs.
- Update safety handling templates in line with relevant SOPs.
- Participate in relevant meetings and share information with relevant teams.
- Provide internal support to other departments.
- Involved in improvement projects with other departments.
- Actively contribute to organizational development and routine enhancements.
- Validate computer applications specific to the department regarding drug safety requirements.
- Stay informed and updated on pharmacovigilance laws, directives, and guidelines.
- Mentor and supervise new Drug Safety staff.
- Participate in marketing initiatives.
Qualifications:
- Bachelor's degree in a life science or nursing field; or equivalent.
- Proven experience working as a QPPV or Deputy QPPV.
- Able to work in a fast-paced environment with changing priorities.
- Familiarity with medical terminology and science related to assigned medications and therapeutic areas.
- Understanding of Pharmacovigilance legislation.
- Ability to work independently and as part of a team with minimal supervision.
- Excellent written and verbal communication skills.
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